OA: Laparoscopy to Predict the Result of Primary Cytoreductive Surgery in Patients With Advanced Ovarian Cancer

 also refer to prior blog posting (2012):

 Tuesday, January 24, 2012

open access - BMC Cancer Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study (protocol/design/Netherlands)

Study protocol

Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study

BMC Cancer 2012, 12:31 doi:10.1186/1471-2407-12-31          ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
open access:
Laparoscopy to Predict the Result of Primary Cytoreductive Surgery in Patients With Advanced Ovarian Cancer: A Randomized Controlled Trial: Journal of Clinical Oncology
 

Patients

Between May 2011 and February 2015, we enrolled 202 patients. One patient was randomly assigned incorrectly because there was no suspicion of advanced-stage ovarian cancer; this patient was therefore excluded from all analyses. Data on the remaining 201 patients were included in the intention-to-treat analysis; 102 were assigned to receive laparoscopy before surgery and 99 to PCS (Fig 1). All patients received a preoperative CT scan of the abdomen and lower thorax and a chest x-ray or CT scan of the thorax. The baseline characteristics were well balanced between the two treatment groups (Table 1).....

                                        
.....The reason for exclusion of patients with expected inoperable disease was to prevent patients from being subjected to laparoscopy or laparotomy when primary surgery was considered unfavorable beforehand. Recently, ASCO published a practice guideline that was based on a systematic review that propagated the same approach wherein all women with a high perioperative risk profile and low likelihood of cytoreduction to < 1 cm are recommended to receive NACT.³¹ PCS is preferred if there is a high likelihood of < 1 cm of residual disease with acceptable morbidity. Furthermore, four other randomized clinical trials that compared primary surgery and NACT with interval surgery in patients with advanced-stage ovarian cancer concluded that NACT was noninferior and the extent of surgery diminished in the NACT arm with decreased complication rates.^5,6,24,32 From these results, we conclude that patients with extensive disease, such as large immobile pelvic tumor or extensive disease of the diaphragm, would benefit most from treatment with NACT.³¹ In addition, Vergote et al⁶ found no survival benefit for either treatment strategy. Therefore, survival was not taken as the primary end point in the current study.
Nevertheless, to our knowledge this randomized clinical study is the first to investigate the role of laparoscopy to prevent futile laparotomies in women with suspected advanced ovarian cancer. Several retrospective or prospective case series have described a diagnostic laparoscopy as a reliable tool to identify women suitable for PCS, but negative predictive values ranged from 69% to 96%, and heterogeneity of the studies made it impossible to draw firm conclusions.^16,33-36 A laparoscopy-based score developed in 2005 to 2006 by Fagotti et al^14,37 showed a positive predictive value of 100% and a negative predictive value of 70% for cytoreductive surgery with < 1 cm of residual disease. This score could not accurately discriminate among women who would be left with > 1 cm of residual disease after validation.^15,38-41 Recently, this model was updated by Petrillo et al³³ to show a higher discriminating performance of laparoscopy, with an area under the curve of 0.89 and a risk of futile laparotomy of 33%, that leaves any residual disease. Despite these limitations, all the aforementioned studies suggested an additive value of laparoscopy, which was the motivation for the current randomized trial.

In conclusion, if complete PCS seems feasible, diagnostic laparoscopy is an effective and safe tool to select patients in whom PCS will be successful in leaving (at least) < 1 cm of residual disease. Therefore, diagnostic laparoscopy should be considered in the diagnostic work-up of women with ovarian cancer to guide treatment selection for either PCS or NACT.